FDA OTC office working with ad division on label-comprehension study protocols.
This article was originally published in The Tan Sheet
Executive Summary
FDA's OTC OFFICE DEVELOPING LABEL COMPREHENSION PROTOCOLS in conjunction with the agency's division of drug advertising "for some of the switches that are coming down the pike," Medical Review Staff Director Deborah Bowen, MD, told a June 28 session of the Drug Information Association's annual meeting in Orlando. "Even if all other [Rx-to-OTC switch] criteria have been met for a particular drug product, it has to have a label which adequately informs and warns consumers about safe and effective use," Bowen commented.
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning